A two-part, randomized, participant- and investigator-blinded, placebo controlled first-in-human study to investigate the safety, tolerability and pharmacokinetics of DCY636 in a single ascending dose part in healthy participants and in a multiple dose part in participants with moderate to severe atopic dermatitis (CDCY636A02101)

未提供0 个研究点目标入组 63 人开始时间: 待定

适应症

试验速览

阶段: 不适用
状态: 尚未招募
入组人数: 63

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized

入排标准

年龄范围: 18age old over 至 100age old under（—）
性别: All

入选标准

•Healthy Participants (Part 1)
•Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive.
•Participants with moderate to severe atopic dermatitis (Part 2)
•Males and non-pregnant females age 18 years or older
•Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topicals
•Moderate to severe atopic dermatitis as defined by all of the following:
•EASI score >=12 at screening visit and >=16 at baseline (BL) visit
•GA score >=3 at screening visit and baseline visit
•Total Body surface area (BSA) affected by AD >= 10 % at screening visit and baseline visit
•Peak Pruritus NRS score >=4 at baseline visit, based on weekly average of daily assessment in the week prior to baseline visit

排除标准

•All Participants (Part 1, Part 2)
•Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer.
•Meet any of the prohibited medication use criteria at baseline visit.
•A positive syphilis test result during screening period.
•Evidence of active or latent TB infection, as determined by T-Spot test during screening period.
•History of immunodeficiency diseases, or a positive human immunodeficiency virus (HIV) test result.
•Recent (within last half year) or ongoing helminth infection.
•History of hepatitis B or hepatitis C or serologic evidence for viral hepatitis. A positive Hepatitis B virus surface antigen (HBsAg), Hepatitis B virus core antibody (HBcAb) and/or Hepatitis B surface antibody (HBsAb) test during screening period excludes a participant. A positive test for HBsAb can be included if the test for HBsAg and HBcAb are negative and the history of hepatitis B vaccination is known. Participants with a positive Hepatitis C virus (HCV) antibody test should be excluded.
•Healthy Participants (Part 1)
•Women of childbearing potential
•Participants with moderate to severe atopic dermatitis (Part 2)
•Regular use (more than 2 visits per week) of a tanning booth/parlor or extended sun exposure (per investigator judgement) within 4 weeks prior to baseline visit
•Have any chronic, uncontrolled medical condition, which would put the participant at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, cardiovascular, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per investigator judgment
•Women of childbearing potential (WOCBP) are excluded unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 202 days (= 5 times the terminal half-life) of study treatment after stopping study treatment.

研究者

发起方

未提供

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